The present invention relates to a device for holding a patient""s mouth in an open position during medical, dental and surgical procedures.
Medical professionals frequently perform procedures that require the patient""s mouth to be held in an open position. For example, a patient""s mouth must be held open during endoscopic procedures to provide clearance for an endoscope and other instruments. A patient""s mouth must also be held in an open or semi-open position when dental bite-wing x-ray images are taken. A similar need exists in trauma evaluation and diagnosis of spinal injuries.
Spinal injuries require prompt evaluation by emergency health care providers. Early recognition of possible cervical spine injury (CSI) is of critical importance. Spinal injury may be difficult to diagnose in patients who are uncooperative, have altered mental status, or other distracting injuries. In such cases, it is difficult to obtain radiographic imagery to make a proper evaluation of the patient. During the initial assessment, great care must be taken to adequately stabilize the patient""s spine and undertake cervical spine radiography for optimal patient evaluation. Obtaining proper cervical spine films, particularly the open-mouth odontoid view (OMV), in the pediatric and adult populations can be a challenging experience even under the best patient circumstances. Patient-related concerns include inability to cooperate during the procedure, repeat films, excessive radiation exposure, and delays in care.
Data from the National Spinal Cord Injury Statistics Center (NSCISC) reports that approximately 10,000 new cases of cervical spine injury (CSI) occur annually, with 1,100 of these cases occurring in children. Boys sustain injury more often than do girls and the most common type of CSI is a combined fracture and dislocation injury. The primary mechanism by which children sustain this serious injury involves blunt trauma from motor vehicle crashes, falls and sports-related accidents. Children with congenital anomalies such as Trisomy 21, Klippel-Feil syndrome, mucopolysaccharidosis are at a greater risk for CSI due to bony abnormalities of the spine and laxity of the neck and spine ligaments.
Although CSI in children is rare, it generally carries a greater degree of morbidity and mortality in the younger pediatric population with associated head trauma. Spinal trauma in the young child often occurs in the higher cervical spine area (C1-C3) due to the child""s larger head-to-body ratio and laxity of their ligaments. As the pediatric spine matures, it approaches adult-like configuration by around eight years of age, as described in Herman, M. et al., Cervical Spine Disorders in Children, Orthop. Clin. Nor. Amer. 1999, 30(3): 457-465. Although the adult spine can distribute traumatic forces more evenly throughout the cervical vertebrae, they generally have a higher incidence of CSI than children, and sustain primarily lower C-spine injury below the C3 level, as described in Manary, M. et al., Cervical Spine Injuries in Children, Ped. Ann. 1996, 25(8): 423-428.
It is estimated that 10-25% of patients with CSI suffer extension of their injuries (paralysis or death) from delays in diagnosis, or unwarranted manipulation in the emergency department (ED) setting. Failure to adequately diagnose CSI promptly can lead to severe neurologic disability and morbidity. Two of the more common errors are failure to obtain adequate C-spine roentgenograms and difficulty in x-ray interpretation.
According to the American College of Radiology Appropriateness Criteria and the American College of Surgeons, the xe2x80x9cgolden standardxe2x80x9d for trauma evaluation of the cervical spine area is the three-view x-ray that includes the lateral, the anteroposterior (AP), and the OMV. See American College of Radiology, ACR Appropriateness, Criteria for Cervical Spine Trauma, 1995: 243-246; American College of Surgeons, Advanced Trauma Life Support (ATLS) Manual, 1997: 217-229. Proper cervical spine x-rays for the evaluation of neck pain and neck injury in both children and adults are critical. However, obtaining the OMV x-rays can be technically difficult and time consuming for both the patient and the emergency health care provider. See Buhs, C. et al., The Pediatric Trauma C-spine: Is the Odontoid View Necessary? J. Ped. Surg. 2000, 35(6): 994-997; Bonadio, W., Cervical Spine Trauma in Children: Part 1. General Concepts, Normal Anatomy, Radiographic Evaluation, Am. J. Emerg. Med. 1993, 11(2): 158-165; Schwartz, D. Introduction to Radiology, xe2x80x9cIn: Emergency Radiologyxe2x80x9d, New York: McGraw-Hill, 2000, 1-7, 291; Swischuk, L. et al., Is the Open-Mouth View Necessary in Children Under 5 Years?, Ped. Rad. 2000, 30:186-189. Depending on the patient""s condition, it may be very difficult to have the patient open their mouth and keep the mouth open while radiography is performed. Problems may be attributed to the patient""s age, the patient""s mental impairment, unconsciousness, pain or injury that distracts the patient, inability to open the patient""s mouth, and difficulties in positioning the patient.
Accordingly, it is desirable to provide a comfortable oral device that may used in a variety of applications, including radiography, to securely hold a patient""s mouth in an open position.
In light of the foregoing, the present invention relates to a device for maintaining a patient""s mouth in an open position during a diagnostic, surgical or other medical procedure. The invention may be used in various applications, including but not limited to, radiology, endoscopy, dental treatment and surgical procedures. In radiology, for example, the invention can be used to facilitate OMV x-rays for spinal trauma evaluation. One or more components of the device are formed of radiolucent materials. In this way, the device may be used in applications such as radiography without visually obstructing x-ray images.
One or more inner flanges may be provided on the device that extend into the mouth. The inner flange or flanges may engage the interior of the mouth and teeth to hold the mouth in an open position. Grooved or serrated surfaces may be provided on the inner flanges so that the inner flanges are less prone to sliding or slipping as they contact the patient""s teeth. The device may also have one or more outer flanges. In one embodiment of the invention, the outer flange or flanges form loop handles that assist in placing the device in a patient""s mouth. In another embodiment of the invention, the outer flange or flanges include rests or tabs that support the patient""s lips while the device is inserted in the patient""s mouth.
One or more wings may extend from the device to help keep the device in the patient""s mouth. In one embodiment of the invention, the wings have solid faces and contain an adhesive pad. The adhesive pad adheres to skin around the patient""s mouth when the device is inserted in the patient""s mouth to keep the device in place. In another embodiment of the invention, the wings have hollow apertures. Adhesive tape may be wrapped through the apertures and applied to the skin around the patient""s mouth to keep the inserted device in place. Alternatively, a flexible strap may be inserted through the apertures and pulled over the patient""s head to assist in holding the inserted device in place. The invention will be more fully described by reference to the following drawings.